CoolSculpting and RF for the Submental | NCT03873779

NCT03873779

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Cryolipolysis Followed by Radiofrequency Treatment	Experimental		Device: The ZELTIQ System

Name	Type	Description	Arm Group Labels	Other Names
The ZELTIQ System	Device	Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Unanticipated Adverse Device Effects (UADEs)	UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.	From date of first treatment to 12 weeks after final treatment (up to 24 weeks)
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)	Photos obtained during the study were reviewed by an independent physician reviewer who entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").	Baseline, 12 weeks post radiofrequency treatment

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Fat Layer Thickness	Fat layer thickness was measured using a caliper at the center of the treatment area.	Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Improvement Based on Subject-graded Global Aesthetic Improvement Scale (SGAIS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Male or female subjects ≥22 years of age and ≤65 years of age.
Treatment area skin fold thickness > 1cm (measured by caliper).
Dissatisfaction with the treatment area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
No weight change exceeding 5% of body weight in the preceding month.
Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
Subject has signed a written informed consent form

Exclusion Criteria

Body Mass Index ≥ 46.2 as determined at screening.
Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
Prominent platysmal bands at rest which may interfere with assessment of treatment area.
Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
Treatment with dermal fillers, chemical peels, radiofrequency or laser procedures that may affect contour in the treatment area within the past 6 months.
Botulinum toxin, deoxycholic acid, or other aesthetic drug injections within the treatment area in the past 6 months.
History of facial nerve paresis or paralysis (such as Bell's palsy).
History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
History of prior neck surgery, or prior surgery in the area of intended treatment.
Current infection in and adjacent to treatment area.
Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
Currently taking or has taken diet pills or weight control supplements within the past month.
Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
Active implanted device such as a pacemaker, automatic implantable cardioverter/defibrillator (AICD), drug delivery system, or any other implantable electrical device.
Pregnant or intending to become pregnant in the next 6 months.
Lactating or has been lactating in the past 6 months.
Unable or unwilling to comply with the study requirements including remaining clean shaven for all study visits.
Currently enrolled in a clinical study of an unapproved investigational drug or device.
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Facility	Status	City	State	ZIP	Country	Contacts
Innovation Research Center		Pleasanton	California	94588	United States

ID	Title	Description
FG000	Cryolipolysis Followed by Radiofrequency Treatment	Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Cryolipolysis Followed by Radiofrequency Treatment	Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Unanticipated Adverse Device Effects (UADEs)

UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.

The Safety Population consisted of all participants who received at least one study treatment.

Posted

Count of Participants

Participants

From date of first treatment to 12 weeks after final treatment (up to 24 weeks)

ID	Title	Description
OG000	Cryolipolysis Followed by Radiofrequency Treatment	Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cryolipolysis Followed by Radiofrequency Treatment	Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.